1st Quarter 2008

Using Biomarkers to Optimize Therapeutic Decisionmaking and Improve Product Value

By Thomas F. Goss, Pharm.D., Vice President, Covance Market Access Services;
Gordon Kapke, Ph.D., Vice President, Covance Central Laboratory Services

Today, more than ever before, pharmaceutical and biotechnology companies are required to demonstrate the value of their products in an increasingly competitive commercial marketplace. The use of biomarkers provides an excellent opportunity to optimize therapy selection and demonstrate a compelling value proposition to economic stakeholders. Companies that anticipate the potential economic benefits associated with the use of biomarkers improve the likelihood of demonstrating commercial value to payers and providers, and thus improve the commercial potential of their products by optimizing product utilization - getting the right therapy to the right patient at the right time - to improve the balance of risk and benefit.

Whether in preclinical or Phase III, biomarkers can help increase the speed, cost, and quality of any drug development program. In early drug development, biomarkers help identify early toxicological effects. During late stage clinical trials, they help prove drug safety and efficacy, guide trial design, and support critical development decisions. As a result of their proven utility and future promise, biomarkers are being increasingly embraced by the medical, regulatory, and payor communities.

Biomarkers have been used to develop economic-based value arguments associated with the use of expensive or widely used therapies. Numerous case studies document how biomarker data has been used to optimize therapy decisions and to assess the value of medical technologies from the perspective of commercially-oriented audiences.

Covance provides multidisciplinary research teams to support a full suite of biomarker assay development and validation services. Covance supports biomarker testing services (both large and small scale) across the drug development from early proof of concept to commercial laboratory testing, and through product commercialization for pharmaceutical and biotechnology products.

Contact Covance to learn how we can integrate biomarkers into your development and commercialization plan.